An interventional study of VALIDATE system in Cancer, sponsored by Stanford University. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-13.
Sponsored by Stanford University · Not applicable, Interventional, and Screening
The collection and analysis of family, medical, lifestyle, and environmental exposure history (a Comprehensive Health History or "CHH") can identify critical risk factors for many chronic and life-threatening conditions, including cancer. Despite its importance, CHH is infrequently documented and analyzed in primary-care medical practice due to numerous hurdles, and currently available tools have proven inadequate to address this critical problem. This study will evaluate the Virtual Agent Linked Intelligent Disease Assessment Tool Engine ("VALIDATE") system as an easy to administer, accurate, cost-effective, and clinically useful tool for collecting and analyzing structured CHH data.
Our study's objective is to evaluate the Virtual Agent Linked Intelligent Disease Assessment Tool Engine ("VALIDATE") system as a means to improve the affordability and ease, while maintaining the validity and feasibility, of collecting, assessing, and acting on Comprehensive Health History data.
Virtual Agents (VAs) are fully autonomous and embodied software agents that use both verbal (e.g. speech) and non-verbal modalities (e.g., gaze, gesturing) to simulate a clinician-patient encounter. These agents have already successfully shown advantages to patients for: entering family history data on their own, facilitating medication adherence, providing behavioral health information, serving as clinical interviewers, promoting breastfeeding, and educating about and motivating exercise and weight loss. The VALIDATE system has been developed to be a fully automated alternative to the currently extremely labor-intensive process of collecting and transcribing CHH data. VALIDATE will be evaluated for its capability to significantly diminish clinician time and cost to collect, review, analyze, and document accurate and complete certain CHH data directly from patients at home using their own personal desktop computers. VALIDATE will also be evaluated for its capability to identify valid clinical action, e.g. referral indications for familial cancer assessment based on American College of Medical Genetics and Genomics (ACMG)/National Society of Genetic Counselors (NSGC) and National Comprehensive Care Network (NCCN) Guidelines.
Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
All adults above the age of 18
Exclusion Criteria:
Children under the age of 18
Will be invited to interact with VALIDATE to determine if they meet referral indications for cancer predisposition assessment.
Other: VALIDATE system
Current standard of care will be followed
Will be invited to interact with VALIDATE to answer questions about Family Cancer history and some personal medical and lifestyle history. Based on responses, VALIDATE will determine if they meet referral indications for cancer predisposition assessment.
Percentage of participants satisfied with usage of VALIDATE
At the end of the session, participants will be asked if 1. they enjoyed the process d 2. if they prefer this process versus completing a web or paper form and 3. would they recommend the process to others?
Time frame: Up to sixteen weeks
Concordance of data collection - identified relatives
Accuracy rates will be calculated by dividing the number of VALIDATE identified relatives by the number identified by a trained Clinician
Time frame: Up to sixteen weeks
Concordance of data collection - identified cancers
Accuracy rates will be calculated by dividing the number of VALIDATE identified cancers by the number identified by a trained Clinician
Time frame: Up to sixteen weeks
Number of VALIDATE subjects versus Control subjects identified for further cancer predisposition assessment.
Time frame: Up to sixteen weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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